The purpose of this study is to evaluate the safety and effectiveness of the MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) in providing cerebral embolic protection during carotid artery stenting. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.

The MICHI™ NPS+f is a flow reversal circuit consisting of two proprietary sheaths connected by standard surgical tubing. The sheaths each have a standard hemostasis valve and sidearm. An in-line flow regulator allows the clinician to modify to the flow through the circuit (either high flow or low flow) in addition to permitting temporary cessation of flow.

Device: MICHI NPS+f

Cerebral protection with carotid flow reversal

Other Names:

MICHI NPS+f

ENROUTE Transcarotid Neuroprotection System

Detailed Description:

Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe adverse neurological effects. Most major clinical studies of CAS have used distal filters for cerebral protection and have compared the neurologic complication rates with those of carotid endarterectomy (CEA). Many currently available embolic protection devices, however, have limited efficacy in capturing microembolic debris that is liberated during stenting, pre-dilatation and post-dilatation. Distal protection systems are furthermore limited by the need to cross the lesion prior to deployment. Some studies have shown a relatively high incidence of cerebral infarction even when distal protection devices are employed.

Cerebral protection with carotid flow reversal is a method that was developed as an alternative to the use of distal protection devices. While novel in its approach, this method too has its limitations. Another technique developed employs carotid flow reversal prior to traversing the stenosis and can be accomplished by directly accessing the carotid anatomy without the use of the transfemoral approach. Major benefits to this method include a simpler route to the target lesion and the ability to perform the procedure on patients with severe carotid tortuosity and difficult aortic arch anatomy.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:

Symptomatic: Stenosis must be greater than or equal to 50% as determined by angiogram and the patient has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 180 days of the procedure.

Asymptomatic: Stenosis must be greater than or equal to 70% as determined by angiogram without any neurological symptoms within the prior 180 days.

Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).

Patient is >18 years of age.

Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.

Patient (or their legal guardian) understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Investigational Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.

Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.

Patient meets at least one surgical high-risk criteria.

Exclusion Criteria:

Chronic atrial fibrillation, any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.

Evolving stroke, severe dementia, intracranial tumor, history of spontaneous intracranial hemorrhage within the past 12 months, recent stroke of sufficient size, hemorrhagic transformation of an ischemic stroke within the past 60 days, history of major stroke with major neurological deficit.

Active bleeding diathesis or coagulopathy or will refuse blood transfusion.

Had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.

Recently (<60 days prior to procedure) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.

Recent GI bleed that would interfere with antiplatelet therapy.

Life expectance of < 12 months post procedure.

History of intolerance or allergic reaction to any of the study medications or stent materials.

Myocardial Infarction within 72 hours prior to the intervention.

Has had neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685567